To address the rapidly changing landscape of the COVID-19 outbreak in the US, on March 24, 2020, the FDA announced an emergency investigational new drug (IND) application program that allows healthcare providers to use plasma from convalescing COVID-19 patients to treat patients in the US with serious or immediately life-threatening COVID-19 infections. Noting the possibility that SARS-CoV-2 antibodies found in plasma may be effective against the infection, the agency has committed to “timely response” to emergency IND requests. SARS-CoV-2 is the virus that causes COVID-19.
The FDA has identified 2 tiers of emergency response:
- For time-sensitive emergencies (requiring <4 hour response time), the provider may contact the FDA’s Office of Emergency Operations at 1-866-300-4374 to seek verbal authorization.
- Requests that are not highly time sensitive (allowing for response from the FDA within 4 to 8 hours), the requesting physician may contact the agency by completing Form 3926 and submitting the form by email to CBER_eIND_Covid-19@FDA.HHS.gov
To be eligible for the COVID-19 plasma expanded access program, the FDA requires patients to meet several provisions:
- The patient must have laboratory confirmed COVID-19.
- The patient’s COVID-19 infection must be severe (e.g., labored or rapid breathing, low blood oxygen saturation, lung infiltrates) or immediately life-threatening (e.g., respiratory failure, septic shock, multiple organ dysfunction/failure).
- The patient must provide informed consent.
The legal basis for emergency INDs comes from expanded access provisions in 21 Code of Federal Regulations (CFR) Part 312, Subpart I (IDRAC 95884). The FDA may permit expanded access to an IND for an individual patient when the applicable criteria in 21 CFR 312.305(a), which pertains to all types of expanded access, and the criteria in 21 CRF 312.310(a), which pertains to individual patient expanded access, including in an emergency, are met.
The FDA announcement states that the agency is continuing to work with its government partners including the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) to develop master protocols for use by multiple investigators in order to coordinate the collection and use of COVID-19 convalescent plasma.
Cortellis Links for Emergency INDs/Expanded Access:
Guidance for Industry: Individual Patient Expanded Access Applications: Form FDA 3926 (Final), June-2016 (Updated October-2017) (IDRAC 259578)
Guidance Bulletin: Individual Patient Expanded Access Applications: Form FDA 3926, Updated 09-November-2017 (IDRAC 208215)
Individual Patient Expanded Access Investigational New Drug Application (IND) (Instructions Supplement), April-2017 (IDRAC 229226)
Guidance Bulletin: Expanded Access to Investigational Drugs for Treatment Use – Questions & Answers, Updated 24-October-2017 (IDRAC 165373)
Marketing Authorization Procedures: Procedure for Unapproved Drug Use / Compassionate Use (IDRAC 45950)
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